Transcend CyPass glaucoma implant and cataract surgery in open angle glaucoma patients

ISRCTN	ISRCTN86839890
DOI	https://doi.org/10.1186/ISRCTN86839890
Secondary identifying numbers	TMI-08-01C

Submission date: 18/05/2010
Registration date: 17/06/2010
Last edited: 17/06/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Contact information

Mrs Ginger Clasby
Scientific

Transcend Medical
20 Pacifica, Suite 220
Irvine
92618
United States of America

Email	gclasby@transcendmedical.com

Study information

Study design	Open-label controlled prospective pilot study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A pilot study to assess the safety and efficacy of the Transcend CyPass glaucoma implant in combination with cataract surgery in patients with open angle glaucoma
Study hypothesis	The objectives of the study are to evaluate the safety and effectiveness of the Transcend CyPass implant in combination with cataract surgery in patients with primary open-angle glaucoma (POAG).
Ethics approval(s)	No ethics approval required as this was a prospective registry study with no interventions.
Condition	Primary open angle glaucoma, ocular hypertension
Intervention	Group 1: eyes will undergo both cataract surgery and CyPass implantation and patients will be followed for 12 months following surgery. Group 2: eyes will undergo only cataract surgery and patients will be followed for 12 months following surgery.
Intervention type	Other
Primary outcome measure	Measured at 12 months: 1. Best corrected visual acuity 2. Intraocular pressure (IOP) 3. Manifest refraction 4. Biomicropscopy 5. Gonioscopy 6. Ophthalmoscopy (dilated)
Secondary outcome measures	No secondary outcome measures
Overall study start date	30/04/2008
Overall study end date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	20 patients
Participant inclusion criteria	1. Patients must be age 18 or over, either sex 2. Patients must have diagnosis of primary open angle glaucoma or ocular hypertension (OHT). Also acceptable are patients diagnosed with open angle glaucoma associated with pseudoexfoliation syndrome or pigmentary glaucoma. 3. Candidacy for cataract surgery in the study eye as determined by the clinical judgment of the investigator 4. Patients who have had previous trabeculoplasty glaucoma procedures such as argon laser trabeculoplasty (ALT) or selective laser trabeculoplasty (SLT) 5. Patients must have intraocular pressure (IOP) of greater than or equal to 21 mmHg and less than or equal to 40 mmHg while on maximal tolerated medical therapy, documented at two sequential visits at any time of day, at least 48 hours apart, within 30 days prior to surgery 6. Patients must have sufficient space in the angle to accommodate the device 7. Patients must be able to understand the requirements of the study and be willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits
Participant exclusion criteria	1. Patients with previous glaucoma surgery, including trabeculectomy or implantation of any aqueous shunt device, or the following glaucoma surgeries: viscocanulostomy, cyclophotocoagulation, or collagen implant 2. Patients with any ophthalmic surgery within 3 months in the eye to be treated 3. Patients with diagnosis of angle closure following penetrating keratoplasty, neovascular glaucoma, congenital glaucoma, developmental glaucoma or previous goniotomy 4. Patients with active uveitis within six months or other secondary glaucomas (other than pseudoexfoliation syndrome or pigmentary glaucoma) 5. Patients with best corrected visual acuity less than 20/200 in the fellow eye 6. Patients with clinically significant inflammation or infection within 6 months prior to the study 7. Patients with active diabetic retinopathy 8. Patients who have any uncontrolled systemic disease (e.g., diabetes, hypertension, etc.) in the opinion of the investigator 9. Intolerance or hypersensitivity to topical anesthetics, mydriatics, or components of the device 10. A medical condition, serious illness, or extenuating circumstance that would significantly decrease study compliance, including all prescribed follow-up 11. Any condition that, in the opinion of the investigator, would jeopardize the safety of the patient 12. Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational device 13. Patients who are pregnant or planning to be pregnant during the course of the study
Recruitment start date	30/04/2008
Recruitment end date	30/04/2009

Locations

Countries of recruitment

Malaysia
Mexico
Philippines
United States of America

Study participating centre

Transcend Medical

Irvine
92618
United States of America

Sponsor information

Transcend Medical, Inc.™ (USA)
Industry

c/o Ginger Clasby
20 Pacifica, Suite 220
Irvine
92618
United States of America

Email	gclasby@transcendmedical.com
Website	http://www.transcendmedical.com/index.htm
"ROR"	https://ror.org/028fhxy95

Funders

Funder type

Industry

Transcend Medical, Inc.™ (USA)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan